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510(k) Data Aggregation

    K Number
    K123153
    Device Name
    ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
    Manufacturer
    MEDTRONIC IRELAND
    Date Cleared
    2013-04-09

    (182 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC IRELAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer quide catheters.
    Device Description
    The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus. The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer quide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + SureValve™ Left-Heart Delivery System is available in two models: Attain Command TM + SureValve ™ 6250VC Left Heart Delivery System and Attain Command™ + SureValve™ 6250VS Left Heart Delivery System. With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models. Each model is different with respect to the guide catheter shape and length and dilator length. The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer quide catheters. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities. The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models. The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
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    K Number
    K103095
    Device Name
    SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
    Manufacturer
    MEDTRONIC IRELAND
    Date Cleared
    2010-10-22

    (14 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC IRELAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre-dilatation catheter for enlarging coronary luminal diameters during PCI procedures.
    Device Description
    The Medtronic Sprinter Legend 1.25mm RX and OTW are balloon dilatation catheters designed to perform Percutaneous Transluminal Coronary Angioplasty (PTCA). Sprinter Legend 1.25mm RX The device consists of a semicompliant balloon mounted on a Rapid Exchange delivery catheter. The Sprinter Legend 1.25mm RX device has an effective length of 142cm. It will be available in a single balloon diameter of 1.25mm and in balloon lengths from 6mm to 20mm. Sprinter Legend 1.25mm OTW The device consists of a semicompliant balloon mounted on an Over-the-Wire delivery catheter. The Sprinter Legend 1.25mm OTW device has an effective length of 152cm. Similar to Sprinter Legend 1.25mm RX, Sprinter Legend 1.25mm OTW will also be available in a 1.25mm balloon diameter and with balloon lengths from 6mm to 20mm.
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    K Number
    K061480
    Device Name
    ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
    Manufacturer
    MEDTRONIC IRELAND
    Date Cleared
    2006-08-21

    (83 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC IRELAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
    Device Description
    The Attain® 6227DEF Deflectable Catheter Delivery System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The Attain® 6227DEF Deflectable Catheter Delivery System is designed to access the coronary sinus and the chambers of the heart using the percutaneous needle and syringe to access the venous insertion site, the guidewire to access the vein the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter.
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    K Number
    K053431
    Device Name
    ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
    Manufacturer
    MEDTRONIC IRELAND
    Date Cleared
    2006-03-16

    (97 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC IRELAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.
    Device Description
    The Attain Select™ II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter. The Delivery Catheter System is used in conjunction with a commercially available Medtronic Attain outer guide catheter. The outer guide catheter is used to gain coronary sinus access. Together, all three catheters function as a telescoping system that can provide additional sub-selecting capabilities. The 6248DEL Delivery Catheter System is available in two models each containing a straight inner catheter and a delivery catheter with either a 90° or 130° curved tip. The inner catheter in both kits is identical
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